Registry for optimal treatment options for mitral valve issues
Official title: Choice of Optimal Transcatheter Treatment for Mitral Insufficiency Registry
Run by Universitätsklinikum Hamburg-Eppendorf · NCT04688190 · Data updated 2026-11-12
This study looks at how well different treatments work for people with serious mitral valve problems, comparing those who had a new valve implanted to those who weren't able to get that treatment.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 1000 (estimated) |
| Sponsor | Universitätsklinikum Hamburg-Eppendorf Academic / other |
| Locations | 43 sites (Tucson, Arizona and 42 other locations) |
| Status | Recruiting |
| Started | November 1, 2020 |
| Main results expected | December 1, 2030 |
| Study ends | December 31, 2030 |
| Registry record updated | May 7, 2026 |
| Trial ID | NCT04688190 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults with clinically significant mitral insufficiency who have been screened for TMVI.
✕Probably not a fit
Patients under 18 years of age will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This multinational observational study investigates the outcomes of patients with clinically significant mitral insufficiency who underwent transcatheter mitral valve implantation (TMVI) compared to those who were screened for TMVI but deemed ineligible. The study collects and analyzes echocardiography data at baseline and after various interventions, including edge-to-edge repair and surgical options. By examining these outcomes, the study aims to provide insights into the effectiveness of different treatment approaches for mitral regurgitation.
Why it matters
Potential benefit: If successful, this study could help identify the most effective treatment options for patients with mitral regurgitation, leading to improved patient outcomes.
How similar studies have gone: Other studies have shown success with similar observational approaches in evaluating treatment outcomes for heart conditions, suggesting this methodology is promising.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * clinically significant mitral insufficiency * patient underwent screening for TMVI * echocardiography data at baseline (and after TMVI, E2E and surgery) * follow-up of at least 30 days Exclusion Criteria: \- age under 18 years
Where it's running
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Tucson Medical Center
Tucson, Arizona, United States Recruiting -
Cedars-Sinai Medical Center, Los Angeles
Los Angeles, California, United States Recruiting -
Tampa General Hospital
Tampa, Florida, United States Recruiting -
Brigham and Women's Hospital
Boston, Massachusetts, United States Recruiting -
Minneapolis Heart Institute at Abbott Northwestern Hospital
Minneapolis, Minnesota, United States Recruiting -
Morristown Medical Center
Morristown, New Jersey, United States Recruiting
Show 37 more locations
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Montefiore Medical Center
New York, New York, United States Recruiting -
Oklahoma Heart Hospital
Oklahoma City, Oklahoma, United States Recruiting -
Houston Methodist Hospital
Houston, Texas, United States Recruiting -
St Vincent's Hospital
Sydney, Australia Recruiting -
Medical University of Vienna
Vienna, Austria Recruiting -
Québec Heart and Lung Institute (Laval University)
Québec, Quebec, Canada Recruiting -
Toronto Heart Center
Toronto, Canada Recruiting -
St. Paul's Hospital
Vancouver, Canada Recruiting -
Rigshospitalet
Copenhagen, Denmark Recruiting -
CHU Bordeaux
Bourdeaux, France Recruiting -
Lille University Hospital
Lille, France Recruiting -
Civils Hospices of Lyon
Lyon, France Recruiting -
Clinique Pasteur
Toulouse, France Recruiting -
HDZ Bad Oeynhausen
Bad Oeynhausen, Germany Recruiting -
German Heart Center Berlin
Berlin, Germany Recruiting -
Heart Center Bonn
Bonn, Germany Recruiting -
University Hospital of Cologne
Cologne, Germany Recruiting -
Goethe-Universität - University Hospital Frankfurt
Frankfurt, Germany Recruiting -
University Heart and Vascular Center Hamburg
Hamburg, Germany Recruiting -
University Heart Center Lübeck
Lübeck, Germany Recruiting -
Heart Center of the University Medical Center Mainz
Mainz, Germany Recruiting -
German Heart Centre Munich
Munich, Germany Recruiting -
LMU Munich
Munich, Germany Recruiting -
University Medical Center Ulm
Ulm, Germany Recruiting -
Interbalkan Medical Center
Thessaloniki, Greece Recruiting -
ASST Spedali Civili di Brescia
Brescia, Italy Recruiting -
San Raffaele University Hospital
Milan, Italy Recruiting -
IRCCS Humanitas Research Hospital
Milan, Italy Recruiting -
IRCCS Policlinico San Donato
Milan, Italy Recruiting -
University Hospital of Pisa
Pisa, Italy Recruiting -
Rikshospitalet, Oslo University Hospital (OUS)
Oslo, Norway Recruiting -
Poznan University of Medical Sciences
Poznan, Poland Recruiting -
Warsaw Medicover Hospital
Warsaw, Poland Recruiting -
Inselspital Bern
Bern, Switzerland Recruiting -
USZ Zurich
Zurich, Switzerland Recruiting -
Royal Brompton Hospital
London, United Kingdom Recruiting -
St Thomas' Hospital - London
London, United Kingdom Recruiting
Study contacts
- Principal investigator: Lenard Conradi, MD — University of Cologne
- Study coordinator: Sebastian Ludwig, MD
- Email: se.ludwig@uke.de
- Phone: +494074100
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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MITRAL II Pivotal: Transcatheter mitral valve replacement for severe mitral annular calcification
This trial tests whether placing an Edwards SAPIEN transcatheter valve through a transseptal approach helps high-surgical-risk adults with severe mitral annular calcification and symptomatic mitral valve dysfunction.
-
Mitral Valve Calcification Imaging with TrueVue 3D Light Rendering
This study tests how well three-dimensional transesophageal echocardiography with TrueVue transillumination detects mitral valve calcifications compared with CT in adults.
-
Surgical implantation of a polymer prosthetic mitral or aortic valve
This will test a surgically implanted polymer heart valve to see if it is safe and works well for adults who need mitral or aortic valve replacement.
-
Abbott Cephea registry for mitral valve disease
Collects clinical information on adults with symptomatic mitral valve disease to see how correcting the valve with the Cephea system affects outcomes for patients who might be candidates for transcatheter mitral valve replacement.
-
Left atrial shunt to help after mitral valve surgery
This study tests whether making a small opening between the left and right atria during mitral valve repair can relieve high left atrial pressure for adults with primary mitral regurgitation.
-
Observational registry for patients treated with the NeoChord Artificial Chordae System
This study is looking at how well the NeoChord Artificial Chordae System works for people with degenerative mitral valve disease over five years, without needing any extra procedures beyond regular treatment.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.